New Method: Clinical Endoscopy
Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction: multicenter pilot study

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Background

Paclitaxel, with its antitumor effect, may improve the function of metallic stents used for biliary drainage. However, clinical studies that use metallic stents covered with a paclitaxel-incorporated membrane (MSCPM) in the biliary tract of human beings have not been previously carried out.

Objective

To evaluate the safety and efficacy of an MSCPM for patients with malignant biliary obstruction.

Design and Setting

A case series that includes 4 endoscopy centers.

Patients

From July 2003 to August 2006, a total of 21 patients diagnosed with unresectable malignant biliary obstruction.

Intervention

Endoscopic placement of an MSCPM.

Main Outcome Measurements

Stent occlusion, complications, stent patency, patient survival, and the periodic mean concentration of paclitaxel in the blood.

Results

Occlusion of the MSCPM was observed in 9 patients and was caused by bile sludge or clog in 4, tumor overgrowth in 3, and tumor ingrowth in 2. Complications included obstructive jaundice in 6, cholangitis in 3, and 1 patient showed stent migration with cholecystitis. The mean patency of a MSCPM was 429 days (median 270 days, range 68-810 days) and cumulative patency rates at 3, 6, and 12 months were 100%, 71%, and 36%, respectively. The mean survival of patients was 350 days (median 281 days, range 68-811 days). The highest concentration of paclitaxel in the blood was found between 1 and 10 days after insertion.

Limitations

Small number of patients and low rate of pathologic diagnosis.

Conclusions

The endoscopic insertion of MSCPM is technically feasible, safe, and effective in patients with malignant biliary obstruction. In addition, MSCPM may exert local antitumor activity because of the steady release of paclitaxel.

Section snippets

Patients

From July 2003 to August 2006, patients who agreed to the insertion of a MSCPM were prospectively enrolled from 4 endoscopy centers; 3 experienced gastroenterologists performed the ERCP. Inclusion criteria were as follows: obstructive jaundice that resulted from a malignant biliary stricture and inoperability on the basis of the patient's general condition or progressive tumor extension. The protocol was approved by the ethics committees of the participating institutions, and a written informed

Patient characteristics

The mean age of the patients was 74 years (range 50-93 years). The mean follow-up period was 329 days (range 68-811 days). The causes of biliary obstruction were pancreatic cancer in 9 patients (43%), bile-duct cancer in 8 (38%), and ampulla cancer in 4 (19%). A pathologic confirmation of malignancy was obtained for 12 of the 21 patients (57%) (Table 1).

Stent occlusion and complications after MSCPM insertion

MSCPM occlusion was observed in 9 patients (43%); the causes of occlusion were bile sludge or clog in 4, tumor overgrowth in 3, and tumor

Discussion

Paclitaxel has been used clinically in systemic chemotherapy and coronary stents for many years, but there are few clinical studies, either experimental and preliminary, on the long-term effect of paclitaxel on the bile duct via a paclitaxel-integrated biliary stent.11, 12, 13 In our porcine animal model,4 we documented that an MSCPM was safe to the normal bile duct and suggested that further clinical trials with long-term follow-up examination in human beings were needed. In this clinical

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